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React Health (Ventec Life Systems) warned that the internal flow transducer cable connector in VOCSN ventilators can unseat and cause reboots and recurring System Fault 10 alarms, which could interrupt ventilation. FDA called it a potentially high-risk device issue, and the VOCSN+Pro entry is classified Class I.
TierFDA reports no reboots during active ventilation and no serious injuries or deaths, so no drop in care is documented. How tiers are assigned.
According to FDA's early alert (page current as of 23 September 2026), React Health stated that the internal flow transducer (IFT) cable connector in VOCSN ventilators with serial numbers 112786 and higher may partially or fully unseat, causing loss of communication with the IFT board. This can lead to reboots and recurring System Fault 10 alarms, and dropping the device can cause it. FDA said that a reboot interrupting therapy could delay therapy or cause a serious adverse event. The alert covers VOCSN+Pro, VC+Pro, VOCSN, VCSN+Pro, V+Pro, V+Pro Emergency, VC and V*Home, including Japan variants. FDA said no reboots during active ventilation had been reported, that it considers such a reboot during active therapy 'remote', and that as of 12 August 2026 React Health had reported no serious injuries or deaths. React Health sent its customer letter on 17 September 2026. FDA's recall database lists the VOCSN+Pro (model PRT-00490-001) entry as a Class 1 recall, Z-0122-2027, posted 20 October 2026, with 4,369 units in commerce distributed US-wide including Puerto Rico; the root cause was under investigation by the firm. Recommended actions include using backup ventilation as needed, not stopping therapy unless an alternative is available and a clinician instructs it, keeping alternative ventilation equipment ready, continuously monitoring ventilator-dependent patients with trained personnel and pulse oximetry or CO2 monitoring where available, and performing the checkout procedure after a drop or impact.[1,2,3]
None documented (no serious injuries or deaths reported as of 12 August 2026, per FDA).
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